The vagina is made up of three layers: a mucosa of stratified squamous epithelial tissue; the submucosa or lamina propria, containing vascularized connective tissue; and a deeper muscularis, containing smooth muscle. Collagen molecules are produced by cells resident in these tissues which synthesize three polypeptide chains that wrap around one another to form a triple helix. Collagen is a major type of fibrous protein that is a basic structural element of connective tissue, tendon, cartilage, and bone. Each of the collagen chains is approximately 1000 amino acid units in length, with glycine recurring regularly every third unit, and with proline and hydroxyproline recurring very frequently. Cross-linking occurs between the sides, not the ends, of collagen molecules and is coupled with the amino acid composition to give collagen its great strength. Collagen tissue tightening takes place in a direction parallel to an axis of collagen fibers.
The phenomenon of thermal contraction of collagen begins with a denaturation of the triple helix of the collagen molecule. Partial denaturation of collagen tissue results in a contraction of the collagen-rich spaces and provides a “tightening” effect on the overlaying tissue. Patents relevant to aspects of collagen denaturation and exploitation of this for medical or cosmetic purposes include U.S. Pat. No. 5,919,219 to Knowlton for “Method for Controlled Contraction of Collagen Tissue Using RF Energy” and U.S. Pat. No. 5,755,753 to Knowlton for “Method for Controlled Contraction of Collagen Tissue”; and U.S. Pat. No. 5,143,063 to Fellner for “Method of Removing Adipose Tissue.”
Further patents and published patent applications include U.S. Pat. No. 6,350,276 to Knowlton for “Tissue Remodeling Apparatus Containing Cooling Fluid”; U.S. Pat. No. 6,387,380 to Knowlton for “Apparatus for Controlled Contraction of Collagen Tissue”; U.S. Pat. No. 6,425,912 to Knowlton for “Method and Apparatus for Modifying Skin Surface and Soft Tissue Structure”; U.S. Pat. No. 6,453,202 to Knowlton for “Apparatus for Tissue Remodeling”; U.S. Pub 2002/0049483 to Knowlton for “Fluid Delivery Apparatus”; U.S. Pub 2003/0212393 to Knowlton for “hand piece with RD Electrode and Non-Volatile Memory”; U.S. Pub 2003/0236487 to Knowlton for “Method for Treatment of Tissue with Feedback”; and U.S. Pub 2004/0000316 to Knowlton for “Methods for Creating Tissue Effect Utilizing Electromagnetic Energy and a Reverse Thermal Gradient”.
The vaginal tissue of women is stretched during vaginal child birth; at least some of the effects of the stretching are permanent and many women have long term medical consequences. Some consequences include physical problems, such as uterine prolapse, cystoceles, urethroceles, enteroceles, rectoceles, stress urinary incontinence, bowel movement problems, for which surgical options are available. Some consequences may include sexual aspects, as may follow from excessive loosening of the vagina and its opening, the introitus. Such loosening typically occurs with the first vaginal delivery, and the loosening tends to increase with subsequent vaginal deliveries. This effective of looseness in this region may include decreased pressure and friction during intercourse, and as a consequence, decreased sexual pleasure for women and their conjugal partners. Some surgical options can be exercised in an attempt to alleviate these problems, but surgical approaches can bring with them a risk of scarring that is entirely counterproductive with regard to the desired result. More generally, these surgical approaches are not highly popular because of the risks associated with an invasive procedure, in a sensitive area, especially when such procedures are considered medically optional.
Known systems and devices for treating the vagina are less than optimal, including those using radiant energy to modify the collagen. In particular, known systems are not optimized for the manipulation of the device, including the energy applicator (e.g., handle, applicator, etc.) and the cooling of the treated tissue. In addition, existing systems may not regulate the contact with the patient's tissue optimally. Finally, known systems have not proven to be simple to use, lightweight, and intuitive. Described herein are systems, devices, and methods of using them to remodel and treat the mucosal surfaces of the vagina, introitus, and vulva.
Thus, there is a need for effective approaches to treating a loose vagina and introitus with a non-invasive procedure, and particularly for systems and device that simplify and improve the treatment, particularly when applying RF energy. Accordingly, one object of the present invention is to provide systems (including apparatus and devices) and methods for corrective or restorative remodeling of the mucosal surfaces of the vagina, introitus, and vulva.